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Do you develop or implement a new medical technology?

Medical technologies require constant improvements and innovations, including research and development, close co-operation with patients, health care providers and payers. These specific characteristics of medical technology industry imposes a need for detailed assessments and qualified decision making. No matter whether you need to convince an internal board, your investors or a public funding body, the systematic evaluation of economic and social impacts provides evidence for decision making.

To commercialise a new medical device, it is essential to be fully compliant with regulatory requirements and it is needed to prepare a medical device conformity assessment process.

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SERVICES How we can help
Cost Benefit Analysis – CBA
Is your strategic plan, project or task that you are currently solving associated with complex impacts which affect various entities and subjects? The CBA method evaluates the effects of investment decisions on all actors involved. The advantage of using this method is that the benefits, but also the costs (negative impacts) do not necessarily have to be expressed only in money, but also expressed by qualitative parameters (for example, in the form of social, environmental or other qualitative metrics). We choose a suitable method and convert advantages into financial values. Then, the impacts can be effectively assessed.
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Budget Impact Analysis – BIA
Wondering how the use of resources will change after the launching of new technology on the market? What impact will a new treatment intervention have on the budget of stakeholders? By understanding the treatment effect and the target population, knowledge of its size, incidence and prevalence of the disease or the number of hospitalizations or outpatient care associated with the disease, we evaluate the impact of new technology on public or insurance budgets.
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Health Technology Assessment – HTA
Do you need a comprehensive study for decision-making process? Do you need to quantify benefits for introduction to reimbursement schemes or for purchasing a new equipment/service? The development of a new healthcare technology is often associated with the need to demonstrate its effectiveness, to compare the results of individual technologies and their costs with each other or with a set cost-effectiveness threshold. The HTA method is a suitable tool for own purposes or sometimes for the requirements of external entities. This method describes the evidence or lack of evidence on the benefits and costs of health interventions, synthesizes findings on the effectiveness of various health interventions. It evaluates the economic consequences and analyzes costs and cost-effectiveness. With its use, it is also possible to evaluate the social and ethical consequences of the dissemination and use of health technologies, as well as their organizational consequences. It helps identify best practices in healthcare and thus increases safety, improves quality and saves costs.
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Regulatory affairs for medical devices
Do you need a strategy to optimise the conformity assessment process and bring your medical device to the European or global market? Are you looking for a way to set up an effective quality management system (QMS) meeting the regulatory requirements in the field of medical devices? The preparation of technical documentation, consulting or mentoring in the field of medical device regulations is one of our services provided at the international level. We understand changes in healthcare regulations, legislation and standards as an opportunity to increase the efficiency of individual processes from design and development to market surveillance. We perform a gap analysis of your regulatory strategy and set up, design the individual steps, including the necessary tests and verifications, which are necessary for a successful medical device conformity assessment process.
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